NL-OMON55317已完成3 期
A Phase 3, Randomized, Open-label Study to Compare Adjuvant Immunotherapy of Bempegaldesleukin Combined with Nivolumab Versus Nivolumab After Complete Resection of Melanoma in Patients at High Risk for Recurrence (PIVOT-12) - PIVOT-12
ektar Therapeutics0 个研究点目标入组 12 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 12
研究概览
简要总结
Trial ended prematurely
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 12 至 99（—）
入选标准
- •1. Provide written, informed consent to participate in the study and follow the
- •study procedures. The Investigator takes responsibility for ensuring that all
- •vulnerable patients are protected and participate voluntarily in an environment
- •free from coercion or undue influence. (See Section 5.2 for details about
- •obtaining informed consent for adolescent patients.)
- •2. Male or female patients age 18 years or older at the time of signing the
- •informed consent form (ICF) (age 18 years or older where local regulations or
- •institutional policies do not allow for patients < 18 years of age to
- •participate).
- •3. Patients must have an Eastern Cooperative Oncology Group (ECOG) performance
- •status of 0 or 1 (>= 17 years of age)/Lansky Performance Score >= 80% (12 to 16
- •years of age, inclusive) (for details, see Appendix 3).
- •4. Histologically confirmed Stage IIIA (LN metastasis > 1 mm [i.e., at least
- •one LN metastasis measuring > 1 mm at greatest diameter]), IIIB/C/D, or IV
- •(M1a/b/c/d) cutaneous melanoma by AJCC (8th edition) at study entry that has
- •been completely surgically resected within 12 weeks prior to randomization.
- •Patients with presence of in transit or microsatellite disease will be allowed
- •if disease has been completely surgically resected. Patients must have been
- •surgically rendered free of disease with negative surgical margins documented,
- •as applicable. (Please refer to Section 5.2 for details of minimum
- •documentation requirements and Appendix 2 for AJCC 8th edition definitions of
- •TNM and staging.)
- •5. Prior treated central nervous system (CNS) metastases must have magnetic
- •resonance imaging (MRI) evidence of no recurrence for at least 4 weeks after
- •treatment, subjects must be off immunosuppressive doses of systemic steroids (>
- •10 mg/day or equivalent) for at least 14 days prior to study drug
- •administration and must have returned to neurologic baseline post-operatively.
- •(The 4-week period of stability is measured after the completion of the
- •neurologic interventions [i.e., surgery and/or radiation]). (Note:
- •Leptomeningeal disease is excluded.)
- •6. In addition to neurosurgery to treat CNS metastases, adjuvant radiation
- •after the resection of CNS metastasis is allowed. Immunosuppressive doses of
- •systemic steroids (doses >= 10 mg/day prednisone or equivalent) must be
- •discontinued at least 14 days before study drug administration.
- •7. Tumor tissue from biopsy or resected disease must be provided to central
- •laboratory for PD-L1 status analysis. Must have PD-L1 expression classification
- •(>= 1%, < 1%, indeterminate, or not evaluable) prior to randomization.
- •8. Disease-free status documented by a complete physical examination and
- •imaging studies within 28 days prior to randomization (see Table 1 for details
- •of required assessments).
- •9. Demonstrated adequate organ function, as defined below:
- •a. White blood cells >= 2000/µL
- •b. Absolute neutrophil count >= 1500/µL (1.5 × 109/L)
- •c. Hemoglobin >= 9.0 g/dL (90 g/L)
- •d. Platelet count >= 100 × 109/L
- •e. Total bilirubin <= 1.5 × upper limit of normal (ULN) (except patients with
- •Gilbert Syndrome, who must have total bilirubin < 3.0 mg/dL)
- •f. Alanine aminotransferase (ALT) <= 3 × ULN
- •g. Aspartate aminotransferase (AST) <= 3 × ULN
- •h. Serum creatinine <= 1.5 × ULN (133 µmol/L) OR calculated creatini
排除标准
- •1. Use of an investigational agent or an investigational device within 28 days
- •before randomization.
- •2. Female patients who are pregnant or lactating, who plan to get pregnant, or
- •who have a positive serum or urine pregnancy test.
- •3. History of ocular/uveal melanoma or mucosal melanoma.
- •4. Active, known or suspected autoimmune disease. Patients with Type I diabetes
- •mellitus, hypothyroidism only requiring hormone replacement, skin disorders
- •(such as vitiligo, psoriasis, or alopecia) not requiring systemic treatment, or
- •conditions not expected to recur in the absence of an external trigger are
- •permitted to enroll.
- •5. Conditions requiring systemic treatment with either corticosteroids (> 10 mg
- •daily prednisone equivalent) or other immunosuppressive medications within 14
- •days of randomization. Inhaled or topical steroids, and adrenal replacement
- •steroid doses > 10 mg daily prednisone equivalent, are permitted in the absence
- •of active autoimmune disease.
- •6. Prior therapy for melanoma. Exceptions include surgery for the melanoma
- •lesion(s) and/or adjuvant radiation therapy for CNS lesions at least 28 days
- •prior to randomization. Patients must have recovered from all Grade >= 2
- •radiation-related toxicities.
- •7. Prior therapy with interferon, talimogene laherparepvec (Imylgic®), IL-2
- •directed therapy, anti-PD-1, anti PD L1, anti PD L2, anti-CD137, or anti-CTLA-4
- •antibody (including ipilimumab or any other antibody or drug specifically
- •targeting T cell co stimulation or checkpoint pathways).
- •8. History of leptomeningeal disease.
- •9. History of hypersensitivity or allergy to study drug components (for
- •nivolumab, bempegaldesleukin, or any of their excipients).
- •10. History of severe hypersensitivity reaction to any monoclonal antibody.
- •11. Prior malignancy active within the previous 3 years except for locally
- •curable cancers that have been apparently cured, such as basal or squamous cell
- •skin cancer or prior melanoma, superficial bladder cancer, or carcinoma in situ
- •of the prostate, cervix, or breast. Consult with the Medical Monitor about
- •other potential exceptions.
- •12. History of allogeneic stem cell transplant; history of solid organ or
- •tissue transplant that requires systemic use of immune suppressive agents.
- •13. Prior surgery that required general anesthesia within 28 days before the
- •first dose of study treatment; surgery requiring local/epidural anesthesia
- •within 72 hours before first dose.
- •14. Active infection requiring systemic therapy within 14 days prior to
- •randomization.
- •15. History of idiopathic pulmonary fibrosis (including pneumonitis),
- •drug-induced pneumonitis, organizing pneumonia (i.e., bronchiolitis obliterans,
- •cryptogenic organizing pneumonia), or evidence of active pneumonitis on
- •Screening chest CT scan.
- •16. Any positive test result for hepatitis B virus or hepatitis C virus
- •indicating presence of virus (e.g., hepatitis B surface antigen [HBsAg,
- •Australia antigen] positive, or hepatitis C antibody [anti-HCV] positive
- •[except if HCV-RNA negative]).
- •17. Any positive test result for immunodeficiency or active human
- •immunodeficiency virus (HIV 1/2 antibodies).
- •18. Prolonged Fridericia*s corrected QT interval (QTcF) > 450 ms for men and >
- 另有 1 项未显示
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